iBio COVID-19 Vaccine Program: Latest Updates and Timeline

This article provides a detailed chronological overview of the most recent information and latest updates provided by the American biotechnology company iBio regarding its IBIO-200 vaccine for COVID-19, the disease caused by the SARS-CoV-2 virus. IBIO-200 is being developed in partnership with the Chinese company CC-Pharming Ltd.

  • iBio Partners with CC-Pharming to Develop COVID-19 Vaccine
  • iBio Provides Update on Development of COVID-19 Vaccine Candidates
  • What is IBIO-200 and how does the vaccine work?
  • Vaccine Candidates Evaluated in Preclinical Studies at Texas A&M University
  • iBio Partners with the Infectious Disease Research Institute
  • iBio Joins the National Institute for Innovation in Manufacturing Pharmaceuticals and Estimates an Annual Production Capacity of 500 Million Doses at the FastPharming Facility

iBio Partners with CC-Pharming to Develop COVID-19 Vaccine

On February 4th, 2020, American biologics contract development manufacturing organization (CDMO) iBio (NYSE: IBIO) announced its partnership with the Beijing-based biotechnology company CC-Pharming Ltd. to develop, test, and manufacture a vaccine for the virus that causes COVID-19.

The vaccine will be produced at iBio’s FastPharming Manufacturing Facility, a 130,000 square foot facility built in 2010 with funding from the U.S. Department of Defense with the intention to provide “rapid delivery of medical countermeasures” in the event of a pandemic. According to iBio, the factory is capable of producing a variety of biological medicines “using a relative of the tobacco plant as the bioreactor.”

Their plant-based approach to the production of a coronavirus vaccine, which involves the use of automated hydroponics and space-efficient indoor vertical farming systems, will allow iBio and CC-Pharming to quickly grow select plant bioreactors and scale-up the production of vaccine candidates.

Executive Chairman and Chief Executive Officer of iBio Dr. Robert B. Kay stated, “We are optimistic about the potential to combine iBio’s and CC-Pharming’s technical expertise and then deploy the FastPharming System to contribute to the development of a vaccine for this disease.” Prior to the coronavirus pandemic, the FastPharming system was used for the development of vaccine candidates for the seasonal and avian influenza viruses, yellow fever virus, and human papilloma virus, and antibody therapies for the Dengue fever and Ebola viruses.

Chairman and Chief Scientific Officer of CC-Pharming Dr. Kevin Wang stated, “This is an important collaboration to develop plant-derived vaccine strategies for the emerging coronavirus outbreak here in China, and around the world. iBio’s capabilities will enhance our ability to rapidly scale-up vaccine candidate production in effort to combat the 2019-nCoV virus’ threat to global health.”

iBio Provides Update on Development of COVID-19 Vaccine Candidates

On March 18th, 2020, iBio provided an update on the development of its COVID-19 vaccine candidates. According to the press release, within a few weeks, the company created nanoparticle constructs, known as virus-like particles (VLPs), that could potentially be used in a SARS-CoV-2 vaccine. The company filed four provisional patent applications regarding to its VLP platform and other SARS-CoV-2-related technologies on March 11th with the U.S. Patent and Trademark Office.

Co-Chairman and CEO of iBio Dr. Tom Isett stated, “We are pleased with both the speed of our development activities and the quality of the VLPs our technology is yielding in practice. The tightly controlled particle size allows for uniform antigen display, which should translate to a consistent dose response and a highly efficient production process, facilitating a ramp-up to tens of millions of doses if we are successful in the clinic.”

Vice President of Protein Expression Sciences at iBio Dr. Sylvain Marcel stated, “I am optimistic about the potential of our COVID-19 vaccine program. In addition to our core VLP production capabilities, we are coating VLPs with oligomannose so that their glycosylation profile closely resembles that of naturally occurring SARS-CoV-2 viruses. This may allow for more efficient uptake of the vaccine by human antigen presenting cells via their mannose receptors. If so, it could result in enhanced protection against SARS-CoV-2. We look forward to providing further updates on our progress as developments unfold.”

What is IBIO-200 and how does the vaccine work?

The COVID-19 vaccine under development by iBio is known as IBIO-200 and consists of virus-like particles (VLP), molecules that are structurally similar to live virus particles but that are inactive due to a lack of infection-causing genetic material (DNA or RNA).

VLPs are sensed by the immune system differently than soluble antigens, which compose the base of many existing vaccines. Both VLPs and soluble antigen can lead to antibody-mediated and cellular immune responses, important outcomes of vaccination.

IBIO-200 is intended to produce a robust anti-viral immune response. The VLPs of IBIO-200 were designed to “maximize uptake” by antigen presenting cells, which communicate with other immune cells to contribute to the promotion and orchestration of an immune response.

Vaccine Candidates Evaluated in Preclinical Studies at Texas A&M University

On March 26th, 2020, iBio announced that preclinical immunization studies of IBIO-200 are underway at laboratories of the Texas A&M University System (TAMUS).

Dr. Tom Isett stated, “This next stage of work on IBIO-200 is critically important as we seek to quickly enter the clinic with one of our VLP candidates. As we optimize our choice of adjuvants with both VLP types we have developed, we are fortunate to have a strong relationship with TAMUS that allows us to rapidly bring their deep insight into the pathogenesis of coronaviruses and experience with vaccine development to the task.”

Head of the Department of Microbial Pathogenesis and Immunology at Texas A&M University Dr. James Samuel stated, “We see strong potential for the IBIO-200 program given that we have both the glycosylated and non-glycosylated iBio VLPs as options for development. We look forward to completing the preclinical immunization studies for iBio to determine the optimal combination of VLP and adjuvant to advance to human clinical trials.”

This collaboration between TAMUS and iBio follows the establishment of a Master Joint Development Agreement between the institutions in 2016.

iBio Partners with the Infectious Disease Research Institute

On April 9th, 2020, iBio announced the signing of a Memorandum of Understanding (MoU) and two Master Services Agreements (MSAs) with the Infectious Disease Research Institute (IDRI), a Seattle-based nonprofit global health organization dedicated to infectious disease research.

According to the MSAs, the IDRI will “support pre-clinical development” and “provide clinical trial oversight” during the pre-clinical and clinical testing and use of IBIO-200. If iBio includes an IDRI-developed adjuvant in the IBIO-200 vaccine, according to the MoU, iBio and the IDRI should “establish a separate, additional agreement within the next 60 days.”

Dr. Tom Isett stated, “We are delighted to have IDRI contribute its deep understanding of infectious diseases and vaccine development expertise to the team. We are also looking forward to evaluating the novel adjuvants in IDRI’s portfolio that may deliver even greater immunostimulatory effects. A more potent antigen-adjuvant combination would further increase our projected manufacturing capacity for production of a vaccine for COVID-19 disease.”

CEO of the IDRI and Clinical Professor of Medicine and Global Health at the University of Washington Dr. Corey Casper, MD, MPH, stated, “We are excited to be a partner in the development of IBIO-200. Combining iBio’s VLP antigen with an IDRI adjuvant provides for promising safety and efficacy characteristics, and importantly, the ready ability to scale-up manufacturing to help meet the projected global demand for a suitable vaccine.”

iBio Joins the National Institute for Innovation in Manufacturing Pharmaceuticals and Estimates an Annual Production Capacity of 500 Million Doses at the FastPharming Facility

On April 27th, 2020, iBio announced that it had joined the National Institute for Innovation in Manufacturing Biopharmaceuticals (“NIIMBL”), an institute of Manufacturing USA that works to “enable more efficient and flexible manufacturing capabilities for existing and emerging biopharmaceutical products, and develop a world-leading biopharmaceutical manufacturing workforce.”

The move is intended to increase the production capacity of iBio’s COVID-19 vaccine. Co-Chairman and CEO of iBio Mr. Tom Isett stated, “If our own proprietary SARS-CoV-2 Virus-Like Particle (“VLP”) program, IBIO-200, results in an approved vaccine, we estimate that we could make about 500 million doses of high-quality product annually at our Texas facility, depending upon the potency we see in the clinic.”

Here is a more detailed account of iBio’s partnership with the NIIMBL.

In addition to iBio, other companies are developing therapeutics for the SARS-CoV-2 virus. The safety and efficacy of a COVID-19 vaccine developed by Inovio Pharmaceuticals is currently being evaluated in human trials and the pharmacologic agent Remdesivir, marketed by Gilead Sciences, is currently being investigated for the treatment of COVID-19 in multiple phase 3 clinical trials.